ClinicalTrials.gg
CompletedNCT01855256H²OUpdated Dec 3, 2025

Treatment of Hyperhidrosis With Oxybutynin

A Phase 3 interventional study of Oxybutynin and Placebo in Hyperhidrosis, sponsored by University Hospital, Brest. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by University Hospital, Brest · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Evaluation of the effectiveness of oxybutynin in hyperhidrosis

02

Conditions studied

  • Hyperhidrosis

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Keywords

  • hyperhidrosis
  • oxybutynin
03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 62 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age greater than 18 years
  • Patient affiliated to social security or beneficiary of such a regime
  • Patient able to consent
  • Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.

Exclusion criteria

Exclusion Criteria:

  • Age less than 18 years
  • Patient who can't be followed
  • Patient participating in another clinical trial
  • Pregnant
  • Woman breastfeeding
  • to oxybutynin or any of the
  • Risk of urinary retention related disorders uretroprostatiques
  • Intestinal obstruction
  • Toxic megacolon
  • Intestinal atony
  • Severe Ulcerative Colitis
  • Myasthenia
  • Closure glaucoma the anterior chamber angle or slightly deep
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    oxybutynin

    Oxybutynin was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.

    Drug: Oxybutynin

  • Placebo comparator
    Placebo

    Placebo was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.

    Drug: Placebo

Interventions

  • Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.

  • DrugPlacebo

    Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.

06

What researchers measure

Primary outcomes

  1. Evaluation of the effectiveness of oxybutynin in hyperhidrosis

    Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )

    Time frame: 6 weeks

Secondary outcomes

  1. Safety evaluation of treatment in this indication

    Number of Participants with Adverse Events will be followed.

    Time frame: 6 weeks

07

Study locations

4 sites
  • CHG de Morlaix
    Morlaix, France 29600, France
  • Hospital, Brest
    Brest, 29609, France
  • CHG Landerneau
    Landerneau, 29800, France
  • Dermatologist'S Office
    Quimper, 29000, France
08

References and documents

Publications

  • Schollhammer M, Brenaut E, Menard-Andivot N, Pillette-Delarue M, Zagnoli A, Chassain-Le Lay M, Sassolas B, Jouan N, Le Ru Y, Abasq-Thomas C, Greco M, Penven K, Roguedas-Contios AM, Dupre-Goetghebeur D, Gouedard C, Misery L, Le Gal G. Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. Br J Dermatol. 2015 Nov;173(5):1163-8. doi: 10.1111/bjd.13973. Epub 2015 Oct 14. PubMed 26114588 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Feb 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2013
First posted
May 16, 2013
Start
Jun 2013
Primary completionActual
Feb 2014
CompletionActual
Mar 2014
Last update
Dec 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01855256
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
May 16, 2013
Start date
Jun 2013
Primary completion
Feb 2014
Completion
Mar 2014
Last update
Dec 3, 2025

Study contacts

Martine SCHOLLHAMMER, MD
principal investigator · ADBO

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Oxybutynin

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